NCT04253626

Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Completed Phase 3 Results posted Last updated 26 August 2025

What this trial tests

Phase 3 trial testing Ferumoxytol Injection [Feraheme] in Pregnancy Related in 83 participants. Completed in 1 July 2024.

Timeline

21 January 2021

Primary endpoint
1 July 2024

1 July 2024

Quick facts

Lead sponsor	Stanford University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	21 January 2021
Primary completion	1 July 2024
Estimated completion	1 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Ferumoxytol Injection [Feraheme] — full drug profile →
• Ferrous Sulfate — full drug profile →

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →
• Anemia, Iron Deficiency — all drugs for Anemia, Iron Deficiency →

Sponsor

Stanford University

Who can join

18 and older, female only, with Pregnancy Related or Anemia, Iron Deficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Change in Hemoglobin Value Before and After Intervention Primary · From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Hemoglobin is measured as g/dL at enrollment and after the study intervention

Group	Value	95% CI
Oral Iron	10.95	9.88 – 11.18
Intravenous Iron	11.45	11.13 – 12.03

Number of Participants Who Discontinued Treatment Secondary · From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Group	Value	95% CI
Oral Iron	6
Intravenous Iron	1

Number of Participants With Serious Adverse Events Associated With Treatment Secondary · From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Group	Value	95% CI
Oral Iron	0
Intravenous Iron	0

Number of Participants Who Need Blood Transfusion Postpartum Secondary · From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Group	Value	95% CI
Oral Iron	3
Intravenous Iron	0

Change in Short Form (SF-)36 General Health Symptom Score Secondary · From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)

Baseline

Group	Value	95% CI
Oral Iron	63	44 – 63
Intravenous Iron	63	50 – 63

Change at week 4

Group	Value	95% CI
Oral Iron	0	-13 – 3
Intravenous Iron	0	-13 – 0

Change in Short Form (SF-)36 Physical Functioning Score Secondary · From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).

Baseline

Group	Value	95% CI
Oral Iron	70	65 – 80
Intravenous Iron	70	50 – 90

Change at week 4

Group	Value	95% CI
Oral Iron	-10	-20 – 5
Intravenous Iron	0	-18 – 10

Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score Secondary · From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).

Baseline

Group	Value	95% CI
Oral Iron	38	0 – 100
Intravenous Iron	50	0 – 100

Change at week 4

Group	Value	95% CI
Oral Iron	0	0 – 25
Intravenous Iron	0	0 – 50

Change in Short Form (SF-)36 Energy/Fatigue Score Secondary · From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy).

Baseline

Group	Value	95% CI
Oral Iron	50	30 – 60
Intravenous Iron	40	23 – 60

Change at week 4

Group	Value	95% CI
Oral Iron	0	-10 – 10
Intravenous Iron	10	0 – 30

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Iron - Weeks 1 to 4

Serious: 0/40 (0%)

Deaths: 0/40

Intravenous Iron - Weeks 1 to 4

Serious: 0/40 (0%)

Deaths: 0/40

Oral Iron - Weeks 5 to 8

Serious: 0/40 (0%)

Deaths: 0/40

Intravenous Iron - Weeks 5 to 8

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (9 terms — click to expand)

Reaction	System	Oral Iron - Weeks 1 to 4	Intravenous Iron - Weeks 1…	Oral Iron - Weeks 5 to 8	Intravenous Iron - Weeks 5…
Constipation	Gastrointestinal disorders	—	—	—	—
Nausea/ Vomiting	Gastrointestinal disorders	—	—	—	—
Edema/ Swelling of limbs	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Body aches/ pains	Musculoskeletal and connective tissue disorders	—	—	—	—
Gastrointestinal symptoms not listed	Gastrointestinal disorders	—	—	—	—
Itching	Skin and subcutaneous tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04253626 adverse events section.

Sponsor's own description

Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intravenous Ferumoxytol Compared With Oral Ferrous Sulfate for Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial.
   Igbinosa II, Leonard SA, Iwekaogwu I, Sherwin EB, et al · · 2026 · PMID 41860281 · DOI 10.1097/aog.0000000000006245